Cheaper birth drug allowed, FDA rules

Pregnant women will still be able to get a drastically cheaper version of a new expensive drug that prevents premature birth, federal health officials said Wednesday.

Since the drug was approved, it's been unclear whether women would have to pay $1,500 per dose for the licensed version or could continue to have it made by specialty pharmacies for $10 to $20.

The price increase caused an outcry, and the Food and Drug Administration on Wednesday took the unusual step of declaring that pharmacies can still make the cheap version of the once-a-week shot on an individual basis, as they have for years.

In response, KV Pharmaceutical Co, which has government approval in February to exclusively sell the drug named Makena, said it was committed to making sure all women who need the drug have access to it

Doctors and others welcomed the new drug because it would be easier to get and mean more consistent quality, but were stunned when the $1,500 per dose price was announced. Total cost during a pregnancy could be as much as $30,000.

Makena is a synthetic form of the hormone progesterone. A version first came on the market more than 50 years ago to treat other problems; it was withdrawn in the 1990s, though not for safety reasons.

The drug got a new life in 2003, when a study showed it helps prevent premature birth in women who previously delivered early. Doctors started prescribing it, and pharmacies mixed it.